Healthy Japanese subjects
Conditions
Interventions
Duration: Two weeks Test food: Active capsule Administration: Take one capsule per day after dinner *If you forget to take the test food, take it as soon as you remember. Daily dose should be tak
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy subjects 5. Subjects whose defecation frequency is three to five times per week 6. Subjects whose defecation frequency is relatively few in seven days prior to Scr
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 5. Subjects who take yogurt, lactic acid bacteria beverages, or natto at least four times a week 6. Subjects who are currently taking medications (including herbal medicines) and supplements 7. Subjects who are allergic to medicines and/or the test food related products 8. Subjects who are allergic to grapefruit or citrus fruits 9. Postmenopausal women 10. Subjects who are pregnant, lactating, or planning to become pregnant during this trial 11. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 12. Subjects who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The defecation frequency in period III* *Period III: The 2nd week after consumption of the test food | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The defecation frequency in period II* 2. The numbers of defecation days and amount of defecation in period II and III* 3. The rate of each state for stool shape, stool smell, and exhilarating feeling of defecation in period II and III* 4. The score of the Japanese Version of the Constipation Assessment Scale [middle term] (CAS-MT) at two weeks after consumption (2w) 5. Each item of CAS-MT at 2w 6. The intestinal flora at 2w * Period I: Seven days prior to screening (before consumption: Scr) Period II: The 1st week after consumption of the test food Period III: The 2nd week after consumption of the test food | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed